We are currently searching for a Trial Master File Specialist to support the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.
Duties & Responsibilities
- Manage Trial Master File (TMF) activities for all CTP trials. Develop protocol-specific TMF indexes and plans at trial start, collect and file TMF documents throughout the trial, collaborate with TMF CRO support during and after the trial, and ensure QC of final TMF at the end of the trial.
- Develop processes and SOPs and other documents to support TMF management.
- Ensure adherence to processes and SOPs specific to documents under their management.
- Ensure documents are readily available for audits and inspections.
- Participate in internal or external audits and regulatory authority inspections as needed.
- Participate in working groups as a subject matter expert on TMF activities/needs and evaluation of TMF storage platforms/tools.
- Provide guidance and serve as a TMF resource to colleagues. Draft, edit, and review protocols and operations manuals specific to the research projects.
- Serve as a liaison to the Regulatory Science and Strategy Program Leadership and external collaborators on regulatory-related topics/projects.
- Review and provide input on various research agreements (interagency agreements, clinical trial agreements, etc.) to ensure the program’s needs are met.
- Review documents (monitoring reports, audit reports, etc.) to ensure site or CRO compliance with federal regulations, GCP, ICH guidelines and other regulatory requirements.
- Provide guidance on international regulations and requirements for CTP trial activities conducted outside the U.S.
- Master’s degree; a bachelor’s degree with applicable job experience may be considered. Regulatory Affairs Certification (RAC) preferred.
- Minimum five (5) years of experience in the pharmaceutical/biotechnology industry, government, or equivalent, including minimum three (3) years of clinical document management system experience, preferably with drugs or biologics products.
- Experience participating in internal or external audits and regulatory authority inspections preferred.
- Demonstrates knowledge and understanding of GCP, ICH guidelines and, regulatory requirements for clinical research and TMFs.
- Ability to work independently and as part of a team.
- Strong organizational skills.
- Excellent oral and written communication skills.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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